How CMC & Finance Impact One Another

CMC requires timely and sufficient funding throughout its research, process design, and drug development phase. They also need budgetary insights to plan manufacturing runs, acquire necessary equipment, and hire appropriate human resources. Usually, these are irreversible commitments made over a multiyear time horizon. Additionally, we see CMC estimate material requirements, secure vendor contracts, and evaluate in-house versus outsourcing of activities. When outsourcing, CMC must address unpredictability from CDMO or testing partners, outcomes from clinical studies, and changes to regulatory requirements. Given these uncertainties, the CMC plan is frequently revised, making it difficult to foretell the value and timing of expenditures.

Meanwhile, Finance requires periodic inputs from CMC to plan for and manage capital and operational investments. The uncertainties in CMC programs make it challenging for Finance to prepare short-term and long-term forecasts. Accurate forecasting is critical for Finance to secure sufficient capital investments. But the inability to raise funds when needed impacts CMC plans and timelines​. This pushes CMC to make internal assessments, aligning with development partners and clinical teams on the downstream impacts of such changes. We find that CMC is not always equipped for analyzing such complexities to provide these assessments. In conversations with CMC and Finance clients, I have seen where differences in perspective and language between these functions are the root cause of issues.

Benefits of a Strong Finance, CMC & Program Management Relationship

Structured collaboration and consistent interactions can close these gaps. When CMC teams can translate program activities and decisions into the language of FP&A, they begin to see and understand the perspective of Finance. They can also better appreciate the financial implications of their work. The same holds for Finance.  It enables both teams to better understand the other’s language, reducing the possibility of miscommunication and poor decision-making in translation. Visibility also provides executive leadership with access to the most recent information in CMC plans and financial budgets for more accurate and confident decisions. It enables more efficient portfolio management discussions, scenario planning and data analysis, leading to swift, cost-effective, and superior decision-making. Executives can better communicate with investors, who in turn feel confident about generating return on their investment.

Strengthening the Relationship amongst Finance, CMC & Program Management

Organizations that do this well build trust and alignment by streamlining the knowledge sharing process and establishing effective communication. CMC program managers (PMs) are in an ideal position to help bridge the gap between CMC and Finance. By leveraging common project management tools such as MS Project, Smartsheets and One Pager Pro, along with other available tools, they can translate CMC plans into financial forecasts that FP&A can use to budget. Mapping tools can make information sharing easier (e.g., tools to analyze the impact of CMC PO/invoice on budgets). Moreover, standardization of key technical and financial terms, expense categories, and information gathering formats can help avoid miscommunication.

In a recent engagement, we helped our client build a CMC project management toolkit consisting of detailed project plans linked to a financial forecasting model. The plans captured key activities, inter-dependencies, durations, timelines, milestones, as well as allocated costs and resources. It was designed to directly input costs into a financial planning spreadsheet. The toolkit effectively built a “bridge” that allowed the FP&A team to quickly integrate new information from CMC, develop accurate program forecasts, and feed those forecasts directly into the company budget. The toolkit supported a structured schedule of budget reviews. Executive leadership also gained the ability to customize data views for key strategic discussions and decisions.​